FDA Sponsored Research

UserWise is excited to announce that the U.S. Food and Drug Administration officially accepted our grant application and our Training Decay project is now in full swing! We are assembling a consortium of leading experts in the field of human factors, medical device validation, and quality engineering.

The full description of the consortium and project background can be found in the following slides: Full Description

If you are interested in joining the consortium either as an official member or observer, contact us with your job title, company affiliation, company size (if a manufacturer/sponsor), and educational background. We’re assembling a consortium that appropriately reflects the make-up of medical product producers/distributors in the U.S.

Background Information:

The FDA invited Shannon Clark to present on her proposed training decay research at FDA headquarters in December 2017 to all of the FDA HF experts (e.g. Irene Chan, Shannon Hoste, Hannibey Wiyor, Xin Feng, Kimberly Konston, etc.). Earlier this year, Irene Chan encouraged UserWise to apply for a grant to further research training decay. The FDA then approved our white paper, invited us to submit in the final stage of the grant proposal process, and formally accepted the grant application as a 2-year project.

The research project is called "Training Decay Selection for Medical Product Usability Validation Testing," and it builds upon Clark’s paper, literature review, and presentation about training decay from 2016.

As part of the grant, we are forming a consortium of industry thought leaders who would like to act as volunteer expert reviewers of the protocol and report. These leaders will serve as a consortium of industry experts, and they need to reflect the general population of companies and stakeholders in the U.S.

The involvement includes:

2-hour review of study approach with optional attendance to a presentation on the study scheme.

Potential participation in a 30-minute advisory session in 2019

2-hour review of the report and/or attendance to a findings presentation in 2020